Durvalumab +/− Lenalidomide for T-Cell Lymphoma

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: City of Hope Medical Center

Must not be taking: Immunotherapy, Immunomodulatory drugs

Disqualifiers: HIV, Hepatitis B/C, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 13

Duration: 12 months

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.

Research Team

Christiane Querfeld, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss.

I am a woman who can have children and my pregnancy test is negative.

My condition is confirmed as mycosis fungoides or Sezary syndrome, and it's at an advanced stage.

Exclusion Criteria

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

I am currently being treated for a serious infection.

I do not have a stomach or bowel condition that affects how my body absorbs medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive durvalumab with or without lenalidomide. Treatment repeats every 28 days for up to 13 courses.

12 months

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Durvalumab
• Lenalidomide

Trial Overview The trial is testing the effectiveness of durvalumab alone versus in combination with lenalidomide in treating T cell lymphoma that has returned after treatment. Durvalumab is a monoclonal antibody that may block cancer growth by targeting specific cells, while lenalidomide can stop cancer cells from growing by various mechanisms.

Participant Groups

Group I: Arm II (durvalumab, lenalidomide) Experimental Treatment 3 Interventions

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab) Experimental Treatment 2 Interventions

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+